- Device
- Guardian 4 Sensor
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S051
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2024-07-17
- Decision code
- OK30
- Date received
- 2024-06-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new sterilization site for the sterilization of the Guardian Sensor (4) sensors that are manufactured at Medtronic Puerto Rico Operations Company. The Guardian Sensor (4) is a component of the Guardian Connect system and the MiniMed 670G, 770G, and 780G systems